Phoenix Technology Group Receives 510(k) Clearance from the FDA for the ICON Wide-field Retinal Imaging Platform
Completely reinvented optics and imaging deliver incredible high-resolution, high-contrast images
Pleasanton, CA – October 12, 2017: Phoenix Technology Group, Inc. announced today that is has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Phoenix ICON wide-field retinal imaging platform. The ICON is cleared for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
“High quality digital imaging is essential to bringing efficiency to patient screening while dramatically reducing subjectivity,” said Mike Trese, M.D. of William Beaumont Hospital, Detroit, MI, a leading ophthalmologist and vitreoretinal surgeon. “We have used the ICON platform extensively in the ICU (Intensive Care Unit) and during EUA’s (Evaluation Under Anesthesia) and have obtained outstanding image quality as compared to legacy systems.”
Designed for use in hospitals, medical clinics, and physician’s offices, the ICON hand piece uses direct illumination and a patent-pending optical design that dramatically increases image quality. The hand piece is equipped with quickly interchangeable (white and blue light) LED-based light sources suitable for bright field and fluorescein angiography imaging, making it simple to switch imaging modalities during exams. Dr. Carol Shields, Ocular Oncologist at The Wills Eye Hospital in Philadelphia says the ICON is “able to image peripheral sclerotic vessels that we had not picked up on examination. The resolution and clarity of the ICON is superior to anything else.”
Phoenix founder and Chairman N.A. (Bert) Massie, Ph.D. said “We’re proud to have received the first new 510(k) for this category of device since 2011. Our team was given complete freedom to re-think retinal and ophthalmic imaging, without the constraints of following legacy designs. With entirely reinvented optics and imaging systems, ICON represents break-through technology that produces amazing high resolution and high contrast retinal images.”
By providing both light intensity and gain controls, users have flexibility to adjust light levels to optimize imaging of various regions and structures of interest while balancing the patient’s comfort. Users have the option to capture video or still images, which are stored on the cart computer for later review.
Easy movement of the ICON cart was a key design goal, and the result is a retinal imaging platform packaged as a lightweight and easy to move cart that is more than 100 lbs. lighter than legacy systems. A 6-hour battery adds convenience to its use in the clinic, intensive care unit, and operating room.
About Phoenix Technology Group: Phoenix Technology Group (PTG) contributes to the fight to prevent blindness by providing physicians, clinicians, and researchers around the world with advanced technology to image and understand the eye. Founded by Bert Massie, Ph.D., inventor of the first digital camera for pediatric retinal imaging, our journey began with the creation of the Phoenix MICRON platform for in-vivo imaging of animals in eye research. Today, the MICRON platform is the standard for researchers around the world, combining bright field imaging, image-guided OCT, and focal and Ganzfeld ERG. Our breakthrough innovations with the Phoenix MICRON platform led to us to reinvent wide-field retinal imaging for human clinical applications, resulting in the recently launched Phoenix ICON product line. The ICON platform is a revolutionary retinal imaging platform delivering high-contrast, high-resolution images, with quality you can see. . You’ll find these breakthroughs inside the ICON platform: completely reinvented illumination, optics, and sensor technology, deployed on a modular platform that was designed from the ground-up for ease of use, reliability, and incredible image quality.
Contact: Jen King, Phoenix Technology Group, ph.1.925.485.1100, firstname.lastname@example.org